U.S. patent application number 13/992366 was filed with the patent office on 2013-10-17 for distraction membrane.
This patent application is currently assigned to CelGen AG. The applicant listed for this patent is Domonkos Horvath. Invention is credited to Domonkos Horvath.
Application Number | 20130274819 13/992366 |
Document ID | / |
Family ID | 45315726 |
Filed Date | 2013-10-17 |
United States Patent
Application |
20130274819 |
Kind Code |
A1 |
Horvath; Domonkos |
October 17, 2013 |
DISTRACTION MEMBRANE
Abstract
The present invention relates to an arched membrane and/or a
membrane having rounded edges for regenerating a bone, in
particular a distraction membrane, suitable for callus distraction,
notably in the jaw region, to the use of the membrane for callus
distraction, and to methods for callus distraction.
Inventors: |
Horvath; Domonkos;
(Jestetten, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Horvath; Domonkos |
Jestetten |
|
DE |
|
|
Assignee: |
CelGen AG
Zug
CH
|
Family ID: |
45315726 |
Appl. No.: |
13/992366 |
Filed: |
December 7, 2011 |
PCT Filed: |
December 7, 2011 |
PCT NO: |
PCT/EP2011/006134 |
371 Date: |
June 7, 2013 |
Current U.S.
Class: |
606/86R |
Current CPC
Class: |
A61F 2002/30242
20130101; A61F 2002/30507 20130101; A61F 2002/30593 20130101; A61F
2/28 20130101; A61F 2002/30062 20130101; A61F 2/2803 20130101; A61F
2/2846 20130101; A61F 2002/30245 20130101; A61F 2002/30237
20130101; A61F 2002/30525 20130101; A61F 2310/00023 20130101; A61B
17/68 20130101; A61C 8/0006 20130101; A61B 17/8071 20130101; A61F
2002/30112 20130101; A61B 17/666 20130101; A61F 2002/30784
20130101 |
Class at
Publication: |
606/86.R |
International
Class: |
A61B 17/68 20060101
A61B017/68; A61F 2/28 20060101 A61F002/28 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 10, 2010 |
DE |
10 2010 055 432.4 |
Claims
1. A distraction membrane, comprising a contact surface, a
counter-surface, and rounded edges, at least a sub-region of the
contact surface and a subregion of the counter-surface being
arched.
2. The membrane according to claim 1, wherein the arching has a
radius of at least 5 mm and of no more than 15 mm.
3. The membrane according to claim 1, wherein the membrane has at
least one perforation.
4. The membrane according to claim 1, wherein the membrane
comprises titanium.
5. The membrane according to claim 1, wherein the edges of the
membrane are covered with a non-woven fabric or a film.
6. The membrane according to claim 1 in combination with at least
one actuating element, wherein the membrane is secured to the at
least one actuating element.
7. The membrane according to claim 11, wherein the membrane is
shaped and dimensioned so as to cover at least a portion of a
surface of a jaw bone facing teeth.
8. A method of bone distraction comprising covering at least a
portion of a surface of a bone with the membrane according to claim
1.
9. A distraction device, comprising the membrane according to claim
1, a fixation device, and an actuating element, connecting the
fixation device to the membrane.
10. A kit, comprising the membrane according to claim 1, a fixation
device, and an actuating element for connecting the fixation device
to the membrane.
11. The membrane according to claim 1, wherein the membrane is
shaped and dimensioned for bone distraction in a jaw region.
12. The membrane according to claim 1, wherein the membrane
consists of titanium.
13. The method according to claim 1, wherein the bone is a jaw
bone.
14. A method of bone distraction, comprising covering at least a
portion of a surface of a jaw bone facing teeth with the membrane
according to claim 1.
15. The combination, according to claim 6, of the membrane and the
at least one actuating element, wherein the at least one actuating
element comprises a screw, a string or a toothed rock.
Description
[0001] The present invention relates to a membrane for regenerating
a bone, in particular a distraction membrane, suitable for callus
distraction, notably in the jaw region, to the use of the membrane
for callus distraction, and to methods for callus distraction.
[0002] Bone losses are currently generally filled with bone
substitute material or with autogenous or allogenic bone.
[0003] From a biological view, an autologous spongiosa transplant
is the best substitute material for bone, However, such transplants
are only available to a limited extent and exhibit a high
resorption rate after transplantation.
[0004] The materials and techniques employed in the prior art
frequently provide inadequate bone quality, so that implants, for
example, are not rigidly anchored in the beds. Additionally, the
bone substitute is frequently not sufficiently vascularized, and as
a result the risk of infection is increased. Methods according to
the prior art often also employ growth factors, which significantly
increase the costs of the procedures.
[0005] Instead of using a bone substitute, lacking bone substance
can also be partially filled in by way of bone regeneration.
Segmental osseous discontinuity on long bones can thus be treated
by way of distraction osteogenesis.
[0006] Callus distraction has been known for more than one hundred
years. The most important biological stimulus for osteogenesis is
mechanical stress. Piezoelectrical forces are released in the
process, which activate osteoblasts and osteoclasts. Distraction
osteogenesis induces new bone formation by triggering biological
growth stimuli by slowly separating bone segments. This method
achieves the direct formation of woven bone by way of distraction.
Defined tensile stress during bone generation is essential. If such
defined tensile stress is applied to bone fragments, the
mesenchymal tissues in the gap and on the adjoining fragment ends
show osteogenetic capacity. If sufficient vascular potency exists,
progressive distraction results in metaplasia of the organized
hematoma, also referred to as a blood clot, in a zone of
longitudinally arranged, fibrous tissue, which under optimal
external and internal conditions can convert directly into woven
bone. However, an aggravating factor is that the bone tissue is
subject to highly complex control during regeneration.
[0007] WO 01/91663 A1 and U.S. Pat. No. 5,980,252 describe devices
and methods for callus distraction by way of artificial interfaces,
for example membranes. The membranes used there are flat plates or
flat small plates, which are usually made of metal, for example
titanium. When these plates or small plates are moved for
distraction of the bone, the edges and the lateral faces thereof,
which form the height of the membrane, graze the neighboring
tissue. This results in irritation and further injury of the
neighboring tissue, whereby healing may be worsened.
[0008] In addition, these flat plates can only be used to distract
smaller regions of a bone section that is not planar, which is to
say flat, for example of a jaw, because otherwise the membrane is
not evenly seated against the bone.
[0009] The technical problem underlying the present invention is to
provide a membrane that makes it possible to carry out bone
regeneration methods that overcome the drawbacks of the prior
art.
[0010] The technical problem underlying the present invention is
also to provide membranes, uses thereof and methods that make it
possible to regenerate bone, and in particular regenerate bone by
way of distraction, wherein the tissue adjoining the membrane is
irritated less or injured less than by membranes from the prior
art, or is not irritated or injured at all.
[0011] The technical problem underlying the present invention is
also to provide membranes, uses thereof, and methods that make it
possible to regenerate non-planar bone sections, for example an
alveolar ridge.
[0012] The present invention solves the underlying technical
problem in particular by providing membranes, and in particular
distraction membranes, methods and uses according to the
claims.
[0013] The present invention solves the underlying technical
problem in particular by providing a membrane, also referred to as
a distraction membrane, which is suitable for callus distraction,
especially in the jaw region, wherein the membrane comprises a
contact surface and a counter-surface, and wherein at least a
sub-region of the contact surface and a sub-region of the
counter-surface are arched, The membrane is thus arched over at
least a portion of the length or width of the membrane.
[0014] The present invention also solves the underlying technical
problem by providing a membrane, also referred to as a distraction
membrane, which is suitable for callus distraction, especially in
the jaw region, wherein the membrane comprises a contact surface, a
counter-surface and at least one lateral face, and wherein the
edges between the contact surface and the at least one lateral face
and/or between the counter-surface and the at least one lateral
face are rounded.
[0015] The present invention also solves the underlying technical
problem by providing a distraction membrane suitable for bone
distraction in the jaw region, wherein the distraction membrane
comprises a contact surface, which is used for osteoblasts to line
or adhere to in the region of a bone defect, a counter-surface
located opposite the contact surface, and at least one lateral
face, and wherein at least a sub-region of the contact surface and
a sub-region of the counter-surface are arched, wherein all edges
between the contact surface and the at least one lateral face and
between the counter-surface and the at least one lateral face are
rounded.
[0016] The present invention also solves the underlying technical
problem by providing a distraction membrane suitable for bone
distraction in the jaw region, wherein the distraction membrane
comprises a contact surface, which is used for osteoblasts to line
or adhere to in the region of a bone defect, a counter-surface
located opposite the contact surface, and at least one lateral
face, and wherein at least a sub-region of the contact surface and
a sub-region of the counter-surface are arched, wherein the
distraction membrane has rounded edges, wherein all edges between
the contact surface and the at least one lateral face and between
the counter-surface and the at least one lateral face are
rounded.
[0017] A preferred embodiment is a membrane, also referred to as a
distraction membrane, that is suitable for callus distraction,
especially in the jaw region, wherein the membrane is arched
according to the invention, and wherein the membrane comprises a
contact surface, a counter-surface and at least one lateral face,
and wherein the edges between the contact surface and the at least
one lateral face and/or between the counter-surface and the at
least one lateral face are rounded.
[0018] The present invention also solves the underlying technical
problem by providing a membrane, also referred to as a distraction
membrane, which is suitable for callus distraction, especially in
the jaw region, wherein the membrane comprises a contact surface, a
counter-surface, and at least one lateral face, and wherein the at
least one lateral face is bent, in particular bent toward the
contact surface.
[0019] A preferred embodiment is a membrane, also referred to as a
distraction membrane, that is suitable for callus distraction,
especially in the jaw region, wherein the membrane according to the
invention is arched, and wherein the membrane comprises a contact
surface, a counter-surface and at least one lateral face, and
wherein the at least one lateral face is bent, in particular bent
toward the contact surface.
[0020] In the context of the present invention, a membrane is
understood to mean a medical membrane, which is suitable for the
distraction of a bone, preferably of a jaw bone, especially in the
dental field. Such a membrane is also referred to as a distraction
membrane.
[0021] The present teaching includes, in particular membranes,
distraction devices and methods for bone regeneration, wherein
preferably bones in the jaw region and/or in the periodontal region
are to be regenerated.
[0022] In the present invention, the term `bone regenerations` in
particular is understood to also mean the regeneration of bone
defects, for example after cystectomy, tumor surgery or trauma
surgery or the like, regardless of the topography, and/or in
particular also the regeneration of smaller bone defects caused by
periodontitis, for example.
[0023] In the context of the present invention, a membrane is
understood to mean a body that is plate-shaped, which is to say
planar or flat, in the non-arched state. The membrane has a contact
surface, which is used for osteoblasts to line or adhere to in the
region of a bone defect, and a counter-surface located opposite the
contact surface. These two surfaces can take on any shape, for
example they can be round, oval, quadrangular or polygonal. The
contact surface and the counter-surface of the membrane are
preferably rectangular in the non-arched state. In the non-arched
state, the sizes of these two surfaces in a rectangular membrane
result from the length and width of the membrane. The membrane
additionally has at least one lateral face, and more particularly
four lateral faces if it is a rectangular membrane. In the
non-arched state, the sizes of two of the lateral faces result from
the height and the length of a rectangular membrane, and the sizes
of the two remaining lateral faces result from the height and width
of the membrane. According to the invention, the membrane is as
thin as possible, which means that the sizes of the lateral faces
are several times smaller than the size of the contact surface, and
in the case of a quadrangular membrane, the height of the membrane
is several times smaller than the length and the width of the
membrane.
[0024] In the context of the present invention, a membrane is
preferably a distraction membrane.
[0025] A distraction membrane, which is suitable for bone
distraction in the jaw region, is preferred, wherein the membrane
comprises a contact surface and a counter-surface, and wherein at
least a sub-region of the contact surface and a sub-region of the
counter-surface are arched, and wherein the membrane has rounded
edges.
[0026] A membrane that comprises a contact surface, a
counter-surface and at least one lateral face is preferred, wherein
at least one sub-region of the contact surface and a sub-region of
the counter-surface are arched, and wherein the edges between the
contact surface and the at least one lateral surface and/or between
the counter-surface and the at least one lateral face are
rounded.
[0027] In a preferred embodiment, the entire contact surface and
the entire counter-surface of the membrane are arched.
[0028] Arching in the context of the present invention shall be
understood to mean a curvature of surfaces, in the present
invention the contact surface and the counter-surface. According to
the invention, the membrane is preferably singly arched, which in
the case of a rectangular membrane means that two mutually opposing
lateral faces are curved and the two other lateral faces are not
curved.
[0029] In one embodiment, the membrane is designed as a shell,
which is to say a membrane that is singly or doubly curved or
arched.
[0030] In one embodiment, the membrane is arched so that it has the
shape of a segment of a spherical shell, for example a
hemispherical shell. In a further embodiment, the membrane is
arched so that it has the shape of a cylindrical shell.
[0031] In a preferred embodiment, the radius of the arching
corresponds to the radius of a bone to be treated, for example a
long bone or a cranial bone.
[0032] In a preferred embodiment, the radius of the arching
corresponds to the radius of a ridge of a jaw bone to be
treated.
[0033] In a preferred embodiment, the arching has a radius of at
least 5 mm. In a preferred embodiment, the arching has a radius of
no more than 15 mm. In a preferred embodiment, the arching has a
radius of at least 5 mm and of no more than 15 mm.
[0034] In an alternative embodiment of the invention, the
respective edges that are formed by two lateral faces can be
rounded.
[0035] In a preferred embodiment, the membrane has rounded
edges.
[0036] A membrane that comprises a rectangular contact surface, a
counter-surface and four rectangular lateral faces is preferred,
wherein the contact surface and the counter-surface are arched, and
wherein all the edges of the membrane are rounded.
[0037] In a likewise preferred alternative embodiment, the membrane
is shaped and dimensioned so as to cover at least a portion of the
surface of a jaw bone facing the teeth. A planar or an arched
membrane can thus be provided, which in the planar state, which is
to say in the flat state, is bent approximately in a horseshoe
shape and has a length so that the membrane can cover at least a
sub-region of an alveolar ridge. It is possible, in particular, for
the membrane to cover the majority, for example up to 80%, of an
alveolar ridge, or an entire alveolar ridge. A person skilled in
the art, for example a dental technician, will be readily able to
determine the size and shape of a membrane that is required to
cover a desired alveolar ridge region. Membranes thus shaped can
advantageously be used to treat wider bone defects, for example
bone defects that cover several missing teeth, and even the entire
alveolar ridge.
[0038] The shape and size of the membranes can be ready-made or
individually adapted to the bone defect to be treated.
[0039] In a further embodiment, the membrane has at least one
further arching, and more particularly several additional archings
having smaller radii.
[0040] In a preferred embodiment, the membrane has bent edges. In a
preferred embodiment, the membrane has at least two bent lateral
faces.
[0041] In a preferred embodiment, the membrane has at least one
perforation.
[0042] In a preferred embodiment, the membrane comprises titanium.
In a preferred embodiment, the membrane is made of titanium. In a
further embodiment, the membrane can also be made of a
biodegradable material or comprise the same.
[0043] In a preferred embodiment, the membrane is sand-blasted. In
a preferred embodiment, the contact surface of the membrane is
sand-blasted.
[0044] In a preferred embodiment, the contact surface of the
membrane is coated.
[0045] In a preferred embodiment, the edges of the membrane are
covered with a non-woven fabric or a film.
[0046] In a preferred embodiment, in addition to the rounded
region, the edges of the membrane are covered with a non-woven
fabric or a film.
[0047] In a preferred embodiment, all the edges of the membrane
between the contact surface and the at least one lateral face and
between the counter-surface and the at least one lateral face are
rounded and additionally are covered with a non-woven fabric or a
film.
[0048] In an alternative embodiment, all the edges of the membrane
between the contact surface and the at least one lateral face and
between the counter-surface and the at least one lateral face are
rounded and are not covered with a non-woven fabric or a film.
[0049] In an alternative embodiment, all the edges of the membrane
between the contact surface and the at least one lateral face and
between the counter-surface and the at least one lateral face are
rounded and are not covered with beads or marginal ridges.
[0050] The membrane according to the invention can be intended for
multiple uses or for single use. The membrane is preferably
intended for single use because this is common practice with
medical membranes, and the adhesive power of the surface of the
membrane decreases upon contact with body fluid. The membrane
according to the invention can be intended for single use in
particular if the membrane was individually produced for a
particular bone defect and/or if the membrane comprises
biodegradable constituents, which break down on use.
[0051] In a preferred embodiment, the membrane according to the
invention comprises at least one securing element. In a preferred
embodiment, the securing element is located on the counter-surface
of the membrane. The at least one securing element is used to
secure the membrane to at least one actuating element. A securing
element can be a perforation, an eyelet or an anchor point, for
example. The at least one securing element is preferably a
perforation, and more particularly a perforation for inserting a
screw. If a perforation is used as the securing element, this can
be a round hole, an elongated hole or an angled hole. The membrane
can also comprise several differently shaped perforations. In an
alternative embodiment, the securing element is used to secure a
toothed rack. To this end, the securing element can be a
perforation or a securing point, for example, such as a welding
point or soldering point.
[0052] The present invention also relates to a membrane according
to the invention, wherein the membrane is secured to at least one
actuating element. In one embodiment according to the invention,
the actuating element is a screw, a filament or a toothed rack. The
actuating element is preferably a screw or a toothed rack. It is
particularly preferred for the actuating element to be a toothed
rack. In an alternative embodiment, the membrane is secured to
several actuating elements, in particular screws.
[0053] In a preferred embodiment, the membrane according to the
invention is a membrane for bone regeneration.
[0054] In an alternative embodiment, the membrane according to the
invention is a membrane for periodontal regeneration. Periodontal
regeneration shall be understood to mean regeneration of the
periodontium, which is to say not only of the bone, but also of the
periodontal ligament, the periodontal tissue, the gingiva and the
papilla, for example by way of guided tissue regeneration (GTR). In
a preferred embodiment, the membrane for periodontal regeneration
has such small dimensions that the same can also be used in
interdental spaces. In a preferred embodiment, the membrane for
periodontal regeneration is very thin. In a preferred embodiment,
the membrane for periodontal regeneration is shaped so that the
membrane comprises at least one lobular extension or a segment that
can be inserted into an interdental space. In a preferred
embodiment, the membrane for periodontal regeneration is a
single-piece, two-piece or multi-piece membrane. In a preferred
embodiment, the membrane for periodontal regeneration comprises at
least one securing element for securing a bone screw, for example
at least one perforation.
[0055] The present invention also relates to a membrane according
to the invention for use for callus distraction, in particular for
reconstructing a jaw bone by way of distraction.
[0056] The present invention also relates to a membrane according
to the invention for use for periodontal regeneration by way of
distraction.
[0057] The present invention also relates to the use of a membrane
according to the invention for callus distraction, in particular
for reconstructing a jaw bone by way of distraction.
[0058] The present invention also relates to the use of a membrane
according to the invention for use for periodontal regeneration by
way of distraction.
[0059] The present invention also relates to a distraction device,
comprising a membrane according to the invention, a fixation device
and an actuating element, which connects the fixation device to the
membrane.
[0060] The present invention also relates to a kit, including at
least two of the membranes according to the invention. The present
invention also relates to a kit, including a membrane according to
the invention, a fixation device and an actuating element for
connecting the fixation device to the membrane. The kit preferably
includes directions for use.
[0061] The present invention also relates to a kit, including at
least two of the distraction membranes according to the invention,
in particular for producing a device according to the invention.
The present invention also relates to a kit, including at least one
distraction membrane according to the invention, a fixation device
and an actuating element for connecting the fixation device to the
membrane, in particular for producing a device according to the
invention. The kit preferably includes directions for use.
[0062] The present invention also relates to a method for callus
distraction, in particular for reconstructing a jaw bone by way of
distraction, wherein a membrane according to the invention is
applied to a bone segment to be regenerated and tensile stress is
applied to this membrane by way of a distraction device. Methods in
which the membrane according to the invention can be used are known
from WO 01/91663 A1 or U.S. Pat. No. 5,980,252, for example, the
content of which describes the options for using the membranes
according to the invention based on an example of membranes from
the prior art and is hereby included in the present application.
Without being bound to theory, in particular, a distance of
approximately 1.5 mm between the membrane and the bone is
advantageous at the start of the procedure for such distraction
methods.
[0063] The invention will be described in greater detail hereafter
based on the drawings. In the drawings:
[0064] FIG. 1a shows a membrane of the prior art;
[0065] FIG. 1b shows a membrane according to the invention,
comprising a rectangular contact surface;
[0066] FIG. 1c shows a side view of the membrane of FIG. 1b;
[0067] FIG. 1d shows a membrane according to the invention,
comprising a circular contact surface;
[0068] FIG, 2a shows a membrane according to the invention,
comprising rounded edges;
[0069] FIG. 2b shows an arched membrane having rounded edges;
[0070] FIG. 2c shows a membrane having bent edge regions;
[0071] FIG. 2d shows an arched membrane having bent edge regions
and rounded edges;
[0072] FIG. 3 shows an arched membrane having perforations;
[0073] FIG. 4a shows a membrane comprising an eyelet as a securing
element;
[0074] FIG. 4b shows a membrane comprising a hole as a securing
element;
[0075] FIG. 5 shows a horseshoe-shaped membrane for treating
large-surface-area jaw defects;
[0076] FIG. 6a shows a membrane comprising further archings for
interdental papilla;
[0077] FIG. 6b is an alternative embodiment of the membrane
comprising further archings for interdental papilla;
[0078] FIG. 7 shows a membrane, the contact surface of which is
coated;
[0079] FIG. 8 shows a distraction device, comprising a membrane, a
fixation device, and an actuating element connecting the fixation
device to the membrane in the form of a toothed rack;
[0080] FIG. 9a shows a membrane for periodontal regeneration,
comprising a segment for insertion into an interdental space;
[0081] FIG. 9b shows a membrane for periodontal regeneration,
comprising two segments for insertion into an interdental
space.
[0082] FIG. 1a shows a distraction membrane 101 from the prior art.
The distraction membrane 101 has a contact surface 1, which is not
visible here, and a counter-surface 2. Of the four lateral faces,
the faces 3a and 4a, which adjoin each other, can be seen. Such a
membrane can be used as described in WO 01/91663 A1 and U.S. Pat.
No. 5,980,252, wherein the contact surface 1 faces a bone and the
membrane is moved away, for example pulled away, from the bone at a
particular rate, for example approximately 0.5 mm to 2 mm per day,
and in particular approximately 1 mm per day, using a distraction
device.
[0083] FIG. 1b shows a membrane according to the invention that is
arched. The membrane 100 has a contact surface 1 and a
counter-surface 2. In addition, the membrane has four lateral faces
3a, 3b, 4a and 4b, of which only the two mutually adjoining lateral
faces 3a and 4a can be seen. In a preferred embodiment, the
membrane is singly arched, as shown in FIG. 1b. According to the
invention, the contact surface 1 is concavely curved and the
counter-surface 2 is convexly curved. With a single curvature of
the shown membrane 100 having rectangular faces, two mutually
opposing lateral faces 3a and 3b are curved and the other two
mutually opposing lateral faces 4a and 4b are not curved.
[0084] The arched geometry of the membrane advantageously results
in greater stability of the membrane against warping. This makes it
possible to use distraction membranes having a very small membrane
height, which is to say membrane thickness. This is advantageous
when using such a membrane for callus distraction in the jaw
region, because here the membrane is placed under the mucous
membrane, and membranes having a large height result in tension in
the mucosal flaps, which can cause ischemia associated with tissue
necroses. This can also result in membrane exposure, as a result of
which a membrane that is subject to bacterial colonization has to
be removed. The arched geometry of a membrane according to the
invention now allows stable membranes having a low height to be
used, so that tension on the mucous membrane can be avoided.
[0085] The membrane preferably has a height of no more than 1 mm,
and more particularly of no more than 0.5 mm.
[0086] In a preferred embodiment, the membrane 100 has a length of
at least 5 mm and no more than 120 mm and a width of at least 5 mm
and no more than 120 mm. For example, the membrane can have a
length of approximately 20 mm and a width of approximately 10 mm.
The length and width information applies to the membrane in the
non-arched state. The membrane can in particular have approximately
the width of an alveolar ridge and the length of a portion of the
alveolar ridge or of the entire alveolar ridge.
[0087] A wide variety of suitable materials for distraction
membranes are known to a person skilled in the art. The membrane is
preferably made of a biocompatible material. The membrane is
preferably made of a metal, in particular titanium. Membranes made
of metals such as titanium have the advantage that they are very
stable, despite having a small height.
[0088] However, alternatively, the membrane can also be made of a
biocompatible plastic material.
[0089] The plastic material is preferably a bioresorbable plastic
material. These have the advantage that they do not have to be
removed after the distraction.
[0090] Of course, the membrane can also have rounded edges.
[0091] FIG. 1c shows a side view of the arched membrane 100
according to the invention. Shown is the curved lateral face 3a,
the edge 11 of which adjoins the concave contact surface 1 and the
curved edge 12 of which adjoins the convex counter-surface 2. The
edges 14a and 14b of the lateral face 3a adjoin the lateral faces
4a and 4b.
[0092] The membrane 100 is arched evenly over the entire contact
surface 1. However, it is also possible that only sub-regions of
the contact surface 1 are arched, for example only the center third
of the edge 11 is arched. The radius R of the arching can also be
different in various regions of the contact surface, According to
the invention, the radius R of the arching of the contact surface 1
is preferably adapted to the natural shape of a bone, for example
the shape of a jaw. The radius R of the arching of the contact
surface is preferably at least 5 mm and no more than 15 mm,
particularly preferably at least 5 mm and no more than 12 mm, and
in particular at least 6 mm and no more than 10 mm. The radius R of
the arching of the contact surface 1 is preferably at least 5 mm,
particularly preferably at least 6 mm. The radius R of the arching
of the contact surface 1 is preferably no more than 15 mm,
particularly preferably 12 mm, and in particular no more than 10
mm. The radius R of the arching of the contact surface 1 is
preferably approximately 6 to 7 mm.
[0093] An arched membrane according to the invention thus not only
has the advantage of increased stability with a low height, but
such a membrane is advantageously also shaped so that the arching
is consistent with the anatomical and physiological conditions of
the bone to be regenerated. This allows the bone to be regenerated
over the entire contact surface of the membrane because this
membrane, during distraction, has approximately the same distance
from the regenerating bone at every point.
[0094] Of course, the membrane can also have rounded edges.
[0095] FIG. 1d shows an arched membrane 100 according to the
invention, in which the contact surface 1 and the counter-surface 2
are not rectangular, but circular. Such a membrane thus has only
one lateral face 3.
[0096] Of course, the membrane can also have rounded edges.
[0097] FIG. 2a shows a planar membrane 100 according to the
invention, having rounded edges. A membrane on which all edges are
rounded is preferred. However, it is also possible that only the
edges between the contact surface 1 and the at least one lateral
face 3a, 4a and/or the edges between the counter-surface 2 and the
at least one lateral face 3a, 4a are rounded. Because the lateral
faces 3a, 4a are very narrow due to the low height of the membrane,
it is also possible for the edges between the contact surface 1 of
the membrane 100 and the at least one lateral face 3a, 4a of the
membrane, and between the counter-surface 2 of the membrane 100 and
the at least one lateral face 3a, 4a of the membrane 100, to be
rounded so that the two rounded regions transition into each other.
It is thus possible for the at least one lateral face 3a, 4a to be
rounded. This is shown in FIG. 2b. The edges 14a, 14b between the
individual lateral faces 3a, 4a are also preferably rounded.
Preferably not only the edges, but also the corners of the membrane
are rounded.
[0098] Rounding the edges of a membrane advantageously prevents the
edges from injuring the surrounding tissue, for example by cutting
or crushing the tissue or fine vessels and capillaries, when the
membrane is moved during distraction. Because of the rounded edges
and/or corners, a membrane according to the invention can
advantageously slide past the adjacent tissue without damaging the
same. The rounded edges advantageously make it easier to adapt the
mucous membrane over the membrane.
[0099] FIG. 2b shows an arched membrane 100 having rounded edges
4a, 4b.
[0100] The combination of the arching according to the invention
and rounding of the edges according to the invention advantageously
results in a membrane that protects the adjacent tissue
particularly well during the distraction because the membrane edges
do not compress the fine vessels and capillaries of the adjacent
tissue, which are very important for providing tissue nutrients to
the mucous membrane covering the membrane. This prevents premature
membrane exposure.
[0101] During the distraction of the membrane, the rounded edges
and the arching of the membrane advantageously also prevent a
sudden increase in pressure in the surrounding vessels, especially
the smaller vessels, Preventing such a sudden rise in pressure is
beneficial for wound healing.
[0102] According to a further embodiment, the edges can
additionally be covered with a non-woven fabric or a film. The
non-woven fabric or the film can be bioresorbable or
non-bioresorbable.
[0103] Covering the edges with a non-woven fabric or a film offers
additional protection for the adjacent tissue, in particular if the
membrane is made of a very hard material, such as titanium for
example.
[0104] FIG. 2c shows a planar membrane 100 having rounded edges
14a, 14b, wherein the lateral faces 4a, 4b are also bent toward the
contact surface 1. The membrane is thus bent in at least two outer
regions 23a, 23b of the contact surface 1 and of the
counter-surface 2, in particular it is bent toward the contact
surface 1.
[0105] Bending the at least one lateral face 4a, 4b of the membrane
also protects the adjacent tissue when the membrane is used because
the tissue is seated against the bend, and not against a sharp
edge. The edges therefore do not necessarily have to be rounded
when the lateral faces are bent.
[0106] Because, during use, the membrane 100 is typically moved in
the direction of the counter-surface 2, the lateral faces 4a, 4b
are preferably bent in the direction of the contact surface 1.
[0107] The lateral faces are preferably bent very significantly,
and in particular they are bent so significantly that the edges do
not come in contact with the tissue. For example, the lateral faces
can be rolled in, and in particular can be rolled in with a very
small radius.
[0108] As an alternative, the edges can be bent at an angle of up
to 90 degrees relative to the adjoining membrane surface.
[0109] Of course, the bent lateral faces can also be combined with
rounded edges.
[0110] FIG. 2d shows an arched membrane 100 having rounded edges
14a, 14b, wherein the lateral faces 4a, 4b are also bent toward the
contact surface 1. The bends 23a, 23b of the edges 4a, 4b can be
seen here as amplified arches of the basic arching of the membrane
100. In a preferred embodiment, the bends thus have a radius that
is smaller than the radius R of the basic arching of the
membrane.
[0111] FIG. 3 shows an embodiment of an arched membrane 100,
wherein the membrane 100 is perforated so that the contact surface
1 and the counter-surface 2 are connected to each other by at least
one hole 15, and more particularly by a plurality of holes, which
can be distributed in particular over the entirety of the surfaces.
In a preferred embodiment, the perforation holes have a diameter at
least approximately 0.3 mm and no more than approximately 1.3
mm.
[0112] Perforation holes, and perforation holes having a diameter
of approximately 1 mm in particular, allow capillaries to grow
through the membrane, whereby excellent blood circulation and
immune defense are ensured in the region of the newly formed bone.
The perforations allow good blood flow through the mucous membrane
covering the membrane and through the regenerated tissue between
the membrane and the bone.
[0113] The number of perforation holes preferably varies depending
on the size of the membrane. For example, a membrane having a
length of approximately 20 mm and a width of approximately 10 mm
can have approximately 10 to 20 perforation holes. Such a ratio of
the number of perforation holes to the membrane surface provides an
optimum balance between the total hole surface promoting blood
circulation and the adhesion surface for osteoblasts adhering to
the membrane during the distraction process.
[0114] FIG. 4a shows a membrane 100 that is arched according to the
invention, comprising an eyelet 16 as a securing element. The
eyelet 16 is located on the counter-side 2 of the membrane 100. A
distraction device can also be attached to the eyelet 16, for
example by way of a wire. By virtue of the distraction device, the
membrane 100 can be used for callus distraction in the defect
region of a bone by being pulled away from a bone defect at an
adapted rate of approximately 1 mm per day.
[0115] FIG. 4b shows a membrane 100 that is arched according to the
invention, comprising a hole 17 as a securing element. For example,
a toothed rack of a distraction device can be inserted into the
hole 17 and secured to the membrane 100, for example by way of
welding, in particular laser welding, soldering or gluing.
[0116] FIG. 5 shows a preferred horseshoe-shaped embodiment of the
membrane 100 for treating large-surface-area jaw bone defects.
[0117] The membrane 100 shown, having the contact surface 1 and the
counter-surface 2, can be used, for example, if all the teeth, or a
large number of teeth next to each other, of a jaw are missing and
the jaw bone has to be regenerated so as to be able to perform
implants. If not all the teeth of the jaw are missing, but only a
large number of teeth that are located next to each other, the
membrane 100 can be shortened and adapted accordingly.
[0118] FIG. 6a shows an alternative embodiment of the membrane 100
according to the invention, comprising the contact surface 1 and
the counter-surface 2, in which additional archings 18 for the
interdental papilla are provided. These additional archings 18 are
adapted to the shape of the jaw bone forming the interdental
papilla. The jaw bone is raised between two adjacent teeth in a
region of approximately 2 mm, whereby the periodontium is higher
there than in the region of the teeth. The additional archings can
be provided so as to preserve this raised bone area even after bone
regeneration by way of distraction, In order for the archings to
follow the shape of the interdental papilla, these preferably have
a radius of 0.5 mm to 1.5 mm, in particular approximately 1 mm, and
are located offset by an angle of approximately 90 degrees relative
to the first arching according to the invention. In a planar
membrane, these archings are located along the longitudinal sides
of the membrane running parallel to the alveolar ridge. A person
skilled in the art, for example a dental technician, will be able
to determine without great effort the dimensioning and positioning
of additional archings that follow the shape of interdental
papilla.
[0119] FIG. 6b shows an alternative embodiment of the membrane 100
of FIG, 6a. In this embodiment, the membrane surfaces 1, 2 are
extended downward further between the additional archings 18, so
that the alveolar ridge can also be covered laterally by the
membrane.
[0120] FIG. 7 shows an alternative embodiment of the membrane 100,
in which the contact surface 1 of the membrane 100 is covered by a
coating 19.
[0121] In a preferred embodiment, the contact surface 1 of the
membrane 100 is coated with hydroxylapatite. In a further preferred
embodiment, the contact surface 1 of the membrane 100 is coated
with a bone substitute material, in particular a natural or
synthetic bone substitute material.
[0122] The bone substitute material is preferably a natural bone
substitute material, for example made of the mineral component of
bones, in particular autogenous, allogenic or xenogenic bone, for
example animal bones, and bovine bones in particular. A suitable
bone substitute material is Bio-Oss.RTM., which is available from
Geistlich, for example.
[0123] In a further preferred embodiment, the contact surface of
the membrane is coated with a bone substitute material and a
biodegradable glue, in particular a fibrin glue. The bone
substitute material is preferably joined to the contact surface of
the membrane by way of the fibrin glue. Such a coating
advantageously allows the newly generated bone tissue to adhere to
the membrane before and during the distraction because the bone
tissue can adhere well to the biological substitute material. In
addition, such a coating allows for easy detachment, in particular
even autonomous detachment of the membrane from the newly formed
bone after completion of the distraction, because the fibrin glue
is biodegradable, and thus is biologically degraded and decomposed
during, and in particular after, the distraction. The coating made
of bone substitute material thus detaches from the contact surface
of the membrane. The membrane can be removed without having to be
separated further from the bone, and the bone substitute material
can remain in the restored bone defect.
[0124] FIG. 8 shows a distraction device 200, comprising an arched
membrane 100 having perforations 15, a fixation device 120, and an
actuating element in the form of a toothed rack 130 that connects
the fixation device 120 to the membrane 100. The distraction
membrane 100 is secured to one end of the toothed rack 130. The
toothed rack 130 is curved, but can also be straight. The fixation
device 120 comprises a gear system, in particular a self-locking
gear system, for moving the toothed rack, wherein the gear system
can be disposed in a stationary manner in the region of the bone to
be regenerated, in particular in the oral cavity. The gear system
comprises a housing 121 having a passage and a threaded body 122,
wherein the toothed rack 130 is inserted in the longitudinal
extension through the passage at least substantially without play
through the housing 121, and wherein the threaded body 122 is
rotatably mounted in the housing 121 so that the threaded body 122
and the toothed rack 130 are operatively engaged with each other.
The gear system 120 can be disposed in a stationary manner in the
region of a bone to be regenerated, in particular in the oral
cavity, by way of additional elements of the fixation device 120,
for example brackets or bridges.
[0125] Distraction devices for regenerating bone, comprising a
distraction membrane and an actuating element actuating the
distraction membrane, wherein the actuating element is designed as
a toothed rack, are disclosed in a patent application by the same
inventor, which has the same filing date as the present invention.
The embodiments disclosed therein shall also be considered to be
disclosed for the membrane according to the invention.
[0126] FIGS. 9a and 9b show preferred embodiments of an arched
membrane 100 for periodontal regeneration. The membranes 100 are
very thin and have rounded edges 3a, 4a. The membranes comprise
segments having the surfaces 1b and 2b , which can be inserted into
the interdental spaces. The membrane in FIG. 9a has one such
segment, and the membrane in FIG. 9b has two such segments. Of
course, it is also possible to provide more than two, for example
three or four, segments. The membrane can be inserted both from the
vestibular side and from the lingual side, or simultaneously from
both sides. Such a membrane is preferably used together with bone
screws.
[0127] It is a matter of course that the preferred embodiments
shown in FIGS. 1 to 9 can be arbitrarily combined with each
other.
[0128] The present invention will be described in greater detail
based on the following example and FIG. 10.
[0129] FIG. 10 shows a distraction device 200 comprising an arched
membrane 100 according to the invention. The membrane is connected
to a gear system 120 by way of a toothed rack 130. The gear system
120 is laminated into a bridge 125, which is secured to two teeth
160, 161. A gap having a bone defect 162 of the arched jaw bone 163
is located between the teeth 160, 161. The contact surface 1 of the
membrane 100 is seated against the jaw bone in the bone defect.
Because the membrane 100 approximately follows the arching of the
jaw bone 163, the contact surface 1 is seated thereon evenly.
Without being bound to theory, in particular, a distance of
approximately 1.5 mm between the membrane 100 and the bone 163 is
advantageous. A coagel 164 has formed between the jaw bone 163 and
the membrane 100, with osteoblasts also being present in this
coagel. These osteoblasts can adhere to the contact surface 1 of
the membrane 100. If the threaded body 122 in the housing 121 of
the gear system 120 is now turned using a screwdriver or the like,
the toothed rack 130, together with the membrane 100, moves upward.
The threaded body 122 can be turned so that the membrane 100 moves
away from the jaw bone 163 at a rate of approximately 1 mm per day.
For example, the threaded body 122 can be turned once a day by a
particular revolution, or twice a day by half this revolution. By
lifting the membrane, biomechanical stimuli are applied to the
osteoblasts adhering to the contact surface 1 in the coagel 164,
resulting in osteogenesis. Using the perforations 15 in the
membrane 100, the coagel 164 and the bone callus having formed
therein are provided with sufficient circulation via the tissue 165
located over the membrane 100. Because of the arching of the
membrane 100, the bone defect 162 of the jaw bone 163 is thus
filled with new bone substance, so that the filled-in bone defect
has the convexly shaped arching of the jaw bone 163.
* * * * *